The assay has manifold applications in fundamental research for DNA damage and repair, in genotoxicity testing of novel chemicals and pharmaceuticals, environmental biomonitoring, and human population monitoring. This chapter describes a standard protocol of the alkaline comet assay and points to some ...
sensitivity, and economics of the Kinetic-QCL assay, in conjunction with the ppropriate equipment and software, over both the in vivo rabbit pyrogen test and the more traditional LAL gel-clot assay allow a more in-depth approach to the control of endotoxin in pharmaceuticals and medical devices...
A review of the genotoxicity of marketed pharmaceuticals result in the pre-ICH/OECD standard four-test battery (bacterial mutagenesis, in vitro cytogenetics, mouse lymphoma assay (MLA), in vivo cytogenetics)... SJW Green - 《Mutation Research/reviews in Mutation Research》 被引量: 311发表: 200...
pharmaceuticals | A&D Weighing | a.g scientific | Aalto | Aalto Scientific | aaltoscientific | aat bioquest | aat bioquest inc | AB Biolabs | ab peptides | ab sciex | abbexa | abbiotec | abbott laboratories | abcore-inc | abcysonline | abd | abd serotec | ab-direct | abdserotec | ...
Strategy for developing and optimizing liquid chromatography methods in pharmaceutical development using computer-assisted screening and Plackett-Burman ex... We describe a three-step method development/optimization strategy for HPLC assay/impurity methods for pharmaceuticals, which include multiple-column/mobil...
lateriflora, and their commercial products According to the notification for definition of pharmaceuticals from the Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health ... T Makino,A Hishida,Y Goda,... - 《Natural Medicines》 被引量: 72发表: 2008年 加载更多...
A pyrogenicity test method and assay of endotoxins allows for rapid and ultrahigh sensitivity testing of parenteral pharmaceuticals or medical devices that contact blood or cerebrospinal fluid by employing a Limulus Amoebocyte Lysate (LAL) assay monitored with a photonic-crystal biosensor. The photonic-...
Peak purity determination.The determination of peak homogeneity is an integral part of the protocol in the validation of any kind of HPLC (and CE) analysis of pharmaceuticals. In the course of impurity profiling studies it is especially important to check the peak of the main component for its...
A statistically-oriented study can be performed to demonstratethat the change does not compromise the previously acceptable performance characteristics of the assay.ASSAY TRANSFERAssay transfer assumes both a known intended use of the bioassay in the recipient lab and the associated required capabilityfor...
and ICH Q2(R1) describe the assay performance characteristics (parameters) that should be evaluated for procedures supporting small-molecule pharmaceuticals. Although evaluation of these validation parameters is straightforward for many types of analytical procedures for well-characterized, chemically-based dru...